following a full submission:
ivabradine (Procoralan®) is accepted for restricted use within NHS Scotland.
Indication under review: Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.
SMC restriction: for initiation only in patients whose resting heart rate remains ≥75 beats per minute despite optimal standard therapy.
In a post-hoc subgroup analysis of the pivotal study in patients meeting the licensed indication, ivabradine was significantly more effective than placebo at reducing the risk of a composite of cardiovascular death or hospitalisation for worsening heart failure. However, in patients on the target dose of beta-blocker, ivabradine was not significantly more effective.
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Medicine details
- Medicine name:
- ivabradine (Procoralan)
- SMC ID:
- 805/12
- Indication:
- Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.
- Pharmaceutical company
- Servier Laboratories Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 08 October 2012